Relationship Between Metrnl Expression, IL-1β, and TNF-α in Patients With Peri-Implantitis

ConditionPeri-implantitis

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAtaturk University

About this trial

Peri-implantitis is an inflammatory disease affecting the tissues around dental implants and may lead to progressive bone loss and implant failure. Current diagnosis is mainly based on clinical and radiographic findings, which may not fully reflect the underlying inflammatory activity. Therefore, there is a need for biological markers that may provide additional information about disease-related changes.

This observational study aims to compare the levels of Meteorin-like protein (Metrnl) and selected inflammatory cytokines in peri-implant crevicular fluid obtained from individuals with peri-implantitis and individuals with healthy implants. The study will evaluate Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10). It will also examine the relationships between Metrnl and these inflammatory markers.

The study hypothesis is that Metrnl levels differ between healthy peri-implant tissues and peri-implantitis and are associated with pro-inflammatory and anti-inflammatory cytokine levels. The findings may help clarify the possible role of Metrnl in peri-implant inflammation and its potential as a biomarker for distinguishing peri-implant health from peri-implantitis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals aged 18 years or older

Individuals without systemic disease

Individuals with at least one healthy implant or one implant affected by peri-implantitis

At least 1 year having elapsed since placement of the prosthetic restoration on the relevant implant

Disqualifiers

Pregnant or lactating individuals.

Current smokers.

Use of antibiotics or corticosteroids within the previous 6 months.

Presence of an implant-supported removable prosthesis.

Trial population

The study population will consist of adults with at least one functioning dental implant who are evaluated at the Department of Periodontology, Faculty of Dentistry, Atatürk University. Participants will be classified into two groups according to clinical and radiographic findings: individuals with peri-implantitis and individuals with peri-implant health. Peri-implant clinical parameters and peri-implant crevicular fluid biomarker levels will be evaluated and compared between the groups.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants

are grouped into 2 trial groups

Group A: Peri-Implantitis Group

Group B: Peri-Implant Health Group

Trial outcomes

Primary outcomes

Metrnl Concentration in Peri-Implant Crevicular Fluid

Meteorin-like protein (Metrnl) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in ng/mL. Metrnl concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.

Time frame

At enrollment

Secondary outcomes

IL-1β Concentration in Peri-Implant Crevicular Fluid

Interleukin-1 beta (IL-1β) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-1β concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.

Time frame

At enrollment

TNF-α Concentration in Peri-Implant Crevicular Fluid

Tumor necrosis factor-alpha (TNF-α) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. TNF-α concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.

Time frame

At enrollment

IL-10 Concentration in Peri-Implant Crevicular Fluid

Interleukin-10 (IL-10) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-10 concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.

Time frame

At enrollment

Other outcomes

Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid

The correlation between Metrnl concentration (ng/mL) and IL-1β concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.

Time frame

At enrollment

Area Under the ROC Curve for Metrnl in Distinguishing Peri-Implantitis From Peri-Implant Health

Metrnl concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) and expressed in ng/mL. Its diagnostic ability to distinguish peri-implantitis from peri-implant health will be evaluated using receiver operating characteristic (ROC) curve analysis. Diagnostic performance will be quantified by the area under the ROC curve (AUC), a unitless measure ranging from 0 to 1.

Time frame

At enrollment

Correlation Between Metrnl and TNF-α Concentrations in Peri-Implant Crevicular Fluid

The correlation between Metrnl concentration (ng/mL) and TNF-α concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.

Time frame

At enrollment

Correlation Between Metrnl and IL-10 Concentrations in Peri-Implant Crevicular Fluid

The correlation between Metrnl concentration (ng/mL) and IL-10 concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.

Time frame

At enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ataturk University

Lead sponsor

Source ClinicalTrials.gov

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